Pain and Safety of Microneedles in Oral Cavity

• ClinicalTrials.gov Identifier: NCT03855397
• Recruitment Status: Completed
• First Posted: February 26, 2019
• Last Update Posted: February 26, 2019
• Sponsor: University of Campinas, Brazil
• Collaborator: Texas Tech University
• Information provided by (Responsible Party): Michelle Franz Montan Braga Leite, DDS, MSc, PhD, University of Campinas, Brazil

Study Description

Brief Summary:

A randomized, crossover, double-blind, placebo-controlled, one-session clinical trial with 30 male volunteers was performed to access pain and safety of microneedle topical application in different regions of the oral cavity.

Condition or disease	Intervention/treatment	Phase
Oral Cavity Disease	Other: Microneedle; Other: Hypodermic needle; Other: Flat patch	Not Applicable

Detailed Description:

A randomized, crossover, double-blind, placebo-controlled, one-session clinical trial with 30 male volunteers was performed by applying a microneedle patch in the following regions of the oral cavity: lip (inner lower), buccal (cheek: 1 cm behind the month angle), tongue (dorsal surface), hard palate (anterior region), and attached gingiva (between central and lateral upper incisors). A 30 gauge hypodermic needle and an identical patch but without microneedles sticking out, were used as positive and negative controls, respectively. The application force was standardized to 10N by an applicator composed of a 5 mL syringe and a spring. Insertions were performed with a gap of 30 seconds. Pain and discomfort associated to the procedure was evaluated with a Visual Analogue Scale (VAS), by a blinded-dentist. The safety associated to microneedle application was verified immediately after the application (0h) and after the next day (24h). The different application sites were inspected visually for bleeding, ulceration, bruising, redness or swelling.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Pain and Safety of Microneedle Application in the Oral Cavity of Human Volunteers
• Actual Study Start Date: January 16, 2018
• Actual Primary Completion Date: May 25, 2018
• Actual Study Completion Date: December 16, 2018

Arms and Interventions

Arm

Intervention/treatment

Experimental: Microneedles; Application of microneedle patch, 30G hypodermic needle (positive control) and flat patch (negative control) in the lip, buccal, tongue, palatal and gingival mucosa for pain and safety assessment

Other: Microneedle; A microneedle patch (no drug) was applied in the following oral cavity sites: lip, buccal, tongue, palatal and gingival mucosa to access pain, discomfort and safety.; Other: Hypodermic needle; 30 gauge hypodermic needle was inserted in the following oral cavity sites: lip, buccal, tongue, palatal and gingival mucosa.; Other Name: positive control; Other: Flat patch; A flat patch was applied in the following oral cavity sites: lip, buccal, tongue, palatal and gingival mucosa.; Other Name: negative control

Outcome Measures

Primary Outcome Measures :

1. Pain sensitivity assessment by Visual Analogue Scale after microneedle application in the oral cavity [ Time Frame: 30 seconds ]
   Pain was evaluated after microneedles, hypodermic needle or negative control topical application application in different oral cavity sites
2. Number of participants with treatment-related adverse events as assessed by visual inspection of ecchymosis, ulceration, redness, swelling or bleeding after microneedles use in the oral cavity [ Time Frame: 24 hours ]
   Any sign of ecchymosis, ulceration, redness, swelling or bleeding right after and 24 h later applications of the devices in different oral cavity sites

Secondary Outcome Measures :

1. Confirmation of mucosal perforationin the oral cavity after application of the devices [ Time Frame: Right after microneedle application ]
   Mucosal perforation after microneedles application was confirmed by applying gentian violet to stain the sites of microneedle insertion

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 35 Years (Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

- Healthy male

Exclusion Criteria:

- Volunteers were free from cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal and haematological diseases, psychiatric disorders, smokers or alcoholic.

Contacts and Locations

Locations

Brazil

Michelle Franz Montan Braga Leite

Piracicaba, São Paulo, Brazil, 13414903

Sponsors and Collaborators

University of Campinas, Brazil

Texas Tech University

Investigators

• Principal Investigator: Michelle Leite, PhD; University of Campinas, Brazil
• Principal Investigator: Harvinder S Gill, PhD; Texas Tech University

More Information

• Responsible Party: Michelle Franz Montan Braga Leite, DDS, MSc, PhD, Principal Investigator, University of Campinas, Brazil
• ClinicalTrials.gov Identifier: NCT03855397
• Other Study ID Numbers: CAAE: 42926115.3.0000.5418
• First Posted: February 26, 2019
• Last Update Posted: February 26, 2019
• Last Verified: January 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Michelle Franz Montan Braga Leite, DDS, MSc, PhD, University of Campinas, Brazil:

Microneedles; Buccal mucosa; Transbuccal administration

Additional relevant MeSH terms:

Mouth Diseases; Stomatognathic Diseases